A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

BACKGROUND: MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. METHODS: We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. FINDINGS: Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], pnon-inferiority=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups. INTERPRETATION: The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. FUNDING: The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

Impact of diabetes on survival in patients with ST-segment elevation myocardial infarction treated by primary angioplasty: insights from the POLISH STEMI registry.

BACKGROUND: It has been shown that, among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with a significantly higher mortality. The aim of this study was to investigate in a large cohort of patients the impact of diabetes on mortality in a large cohort of patients with STEMI treated with primary angioplasty. METHODS: Our population is represented by consecutive patients with STEMI treated by primary angioplasty and enrolled in the POLISH registry in 2003. All clinical, angiographic, and follow-up data were prospectively collected. Diagnosis of diabetes was based on history of diabetes at admission. RESULTS: Among 7193 patients, 877 (12.2%) had diabetes at admission. Diabetes was associated with more advanced age (p<0.0001), higher prevalence of female gender (p<0.0001), hyperlipidemia (p<0.0001), shock at presentation (p<0.0001), renal failure (p<0.0001), previous myocardial infarction (p<0.0001), more often treated after 6h from symptom onset (p<0.0001). Diabetes was associated with more extensive coronary artery disease (p<0.0001), less often treated with stenting (p<0.0001). Diabetes was significantly associated with impaired epicardial reperfusion (TIMI 0-2: OR [95% CI]=1.81 [1.5-2.18], p<0.0001), that persisted after correction for baseline confounding factors (OR [95% CI]=1.33 [1.075-1.64], p=0.009). At a mean follow-up of 524+/-194 days, diabetes was associated with higher mortality (unadjusted cumulative mortality: 23.5% vs. 12.6%, unadjusted HR=1.95 [1.66-2.3], p<0.0001), that persisted after correction for confounding factors (adjusted cumulative mortality: 13.3% vs. 10.7%, adjusted HR=1.23 [1.04-1.46], p=0.013). CONCLUSIONS: This study shows that among STEMI treated by primary angioplasty diabetes is independently associated with impaired epicardial reperfusion and higher mortality.

Influence of different antiplatelet treatment regimens for primary percutaneous coronary intervention on all-cause mortality.

AIMS: The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. METHODS AND RESULTS: The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. CONCLUSION: In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.

Facilitated PCI in patients with ST-elevation myocardial infarction.

BACKGROUND: We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI). METHODS: In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization. RESULTS: A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49). CONCLUSIONS: Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)

Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry.

OBJECTIVES: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-months angiographic and 12-months clinical follow-up results. BACKGROUND: First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. METHODS: We conducted a prospective, multicenter first-in-man registry of a novel, locally developed, bioabsorbable-coated, paclitaxel-eluting coronary stent in 116 patients with single-lesion de novo coronary disease. RESULTS: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia-driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core-lab assessed binary in-stent restenosis (> or =50% DS) was noted in 11.9% patients and mean late loss was 0.46 +/- 0.47 mm. CONCLUSIONS: This first-in-man experience obtained in a multicenter registry of real-world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience.

Acute myocardial infarction in the elderly. Is primary coronary angioplasty the treatment of choice? In-hospital follow-up results.

BACKGROUND: Acute myocardial infarction (AMI) is one of the main causes of death in the elderly, however, the optimal therapy of AMI in this age-group has not yet been established. AIM: To compare the early outcome of patients with AMI aged > or =75 years who underwent primary percutaneous coronary interventions (PCI) or were treated conservatively. METHODS: In-hospital outcome of 180 patients aged > or =75 years, hospitalised due to AMI, was retrospectively analysed. Ninety two consecutive patients, admitted with AMI between May 2001 and October 2002, underwent primary PCI whereas 88 patients, treated for AMI between 1993 and 2002, received standard pharmacological therapy without thrombolysis. CONCLUSIONS: Primary PCI in the elderly with AMI is significantly more effective than conservative therapy, except with patients with cardiogenic shock in whom mortality is similar regardless of the therapy used.

The impact of very late revascularization of occluded infarct-related artery on cardiac mortality and the incidence of sudden death in survivors of acute myocardial infarction - long-term observation.

BACKGROUND: In survivors of acute myocardial infarction (AMI), an occluded infarct-related artery (IRA) is an important predictor of cardiac death (CD) and sudden death (SD). Early reperfusion of the IRA was associated with improved survival rate. The purpose of the present study was to assess if late IRA revascularization, performed 10-30 days after AMI, also has a beneficial effect on the incidence of CD and SD during an 18-month follow-up. MATERIAL/METHODS: The study population consisted of 93 post-MI patients with occluded IRA on coronary angiography. The patients were divided into 2 groups according to IRA status at discharge -- revascularized (47 patients) or occluded (46 patients) -- and followed. Before revascularization, the two groups of patients did not differ in the prevalence of clinical and angiographic variables, or in the incidence of risk factors for SD. In patients who underwent angioplasty or bypass graft surgery of closed IRA, the markers of electrical instability demonstrated no significant improvement after revascularization. RESULTS: During the 18-month follow-up a significantly lower incidence of CD (0% vs 15%, p<0.01) and SD (0% vs 11%, p<0.03) was observed in the group of patients with revascularized IRA than in the group of patients with occluded IRA. CONCLUSIONS: In survivors of AMI, late reperfusion of occluded IRA is associated with reduced 18-month cardiac mortality. The beneficial effect of this procedure on the incidence of sudden death, not associated with improvement in myocardial electrical stability, suggests that ischemia can be considered an important factor modulating the arrhythmogenic substrate.